Clinical Trial Patient Criticizes Study That Led to FDA Approval of Essure

EssurePBCBoxedLogo(SOURCE) A participant in a clinical trial for the birth control device Essure — which some women have complained causes them pain and unexplained symptoms — is now criticizing the way doctors conducted the studies that later formed an application for its FDA approval.
 
Kim Hudak, a mother from Cleveland who was part of a trial that looked at 464 women implanted with Essure, believes researchers ignored and even redacted painful problems she reported in follow-up appointments and phone surveys during the clinical trial. 
 
“There are so many symptoms and I really thought I was losing my mind. I thought nobody could be this sick,” Hudak said.
 
The birth control method is intended to permanently block pregnancy by implanting two metal coils in a woman’s fallopian tubes. Those coils prompt the development of scar tissue, which creates a barrier to sperm. Hudak says months after the procedure, she began to develop chronic pain symptoms that became debilitating.
 
Seven times during the eight years of follow-up, Hudak told researchers she was experiencing discomfort in her pelvic region and lower back. In 2001, records from the study obtained by the I-Team show she reported that “severe” pain was making it “uncomfortable when breathing or moving.”  In 2002, she reported four-hour episodes of lower back pain. In 2005, Hudak referred to pain during sexual intercourse, child care, and pain that was “constant even when relaxing.”
 
Despite those complaints, survey forms filled out during the clinical trial show Hudak’s “comfort of wearing the device” was “excellent.”
 
Hudak says Dr. Linda Bradley, one of the lead medical investigators for the clinical trial, insisted pain symptoms were unrelated to the Essure implants, so Hudak went along with the characterization that her comfort was “excellent.”
 
“I honestly didn’t feel like she was listening to what I was saying and I thought it was important.  I was a clinical trial participant. I thought that whatever I was saying, even if it didn’t seem related, should be taken seriously,” Hudak said.